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MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors recallZ-1186-2024 · Avanos Medical, Inc. · initiated Jan 16, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Avanos Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

FDA root cause category: Nonconforming Material/Component

What the company is doing

AVANOS MEDICAL, INC. issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 01/16/2024 via FedEx. The notice explained the issue, the potential risk to health, and requested the following actions be taken: " Please continue to perform normal post op care for any newly placed MIC GJ tube. Per the Daily Care & Maintenance Check List found in the product Instructions for Use: o Assess the patient for any signs of pain, pressure or discomfort. o Assess the stoma site for any signs of infection, such as redness, irritation, edema, swelling, tenderness, warmth, rashes, purulent, or gastrointestinal drainage. o Assess the patient for any signs of pressure necrosis, skin breakdown, or hypergranulation tissue. " Report any adverse events involving these products immediately to [email protected] " Check all storage facilities and warehouse locations for affected products and quarantine them. " Complete the Customer Response Form. which can be found online: https://iqvia-response.my.site.com/mt/fca?cid=avanos-fca-2024-001, or by using the QR code provided in the Field Correction Acknowledgement Instructions accompanying this letter. " Destroy all affected lots in your inventory per your facility s procedures o Alternatively if you are unable to destroy your affected inventory, please indicate so on the form and you will be provided information on how to return product for destruction. o A refund will be provided to you based on the quantity of affected product you have indicated on the Customer Response Form. " Distributors only: alert your affected customers of this recall. We ask that you work with them to destroy affected product and provide them refunds as per your internal processes. Provide to Avanos an updated response using the Customer Response Form to receive refunds or credit for your customers affected products. " Please reach out to [email protected] or call (855) 201-1355 with any questions or concerns regarding these instructions.

Recall details

Recall number
Z-1186-2024
Status
Open, Classified
Initiated by the company
Jan 16, 2024
Posted by the FDA
Mar 1, 2024
Recalling firm
Avanos Medical, Inc.
Quantity
10808 units
Product code
KNT
FDA submissions
K921370
Distribution
Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including PR; and OUS (foreign) countries of: Canada, Colombia, Costa Rica, UAB, Israel, Kuwait, and Panama.

Product description

MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Surgical Placement - 16 Fr, Product Code 8260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Surgical Placement - 18 Fr, Product Code 8260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Surgical Placement - 22 Fr, Product Code 8260-22

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

a) Product Code 8250-16, UDI/DI 350770445410, Batch Numbers: 30180762, 30226671, 30226823, 30233440, 30238985, 30242039, 30254749, 30265005, 30266483, 30265374, 30268260, 30270862; b) Product Code 8250-16-15, UDI/DI 350770445427, Batch Numbers: 30226822, 30242228, 30253956; c) Product Code 8250-16-22, UDI/DI 00350770445434, Batch Numbers: 30184814, 30226821, 30247088, 30253955, 30262508, 30226820; d) Product Code 8250-16-30, UDI/DI 00350770445441, Batch Numbers: 30231400, 30238125 30247087, 30250300, 30258135, 30265373; e) Product Code 8250-18, UDI/DI 00350770445458, Batch Numbers: 30181846, 30184760, 30185381, 30226672, 30229833, 30233376, 30233439, 30235094, 30238124, 30238984, 30250140, 30251089, 30250169, 30254748, 30255675, 30256486, 80402128, 30259225, 30259566, 30261699, 30262040, 30264284, 30267593, 30268259, 30270505; f) Product Code 8250-18-22, UDI/DI 00350770445465, Batch Numbers: 30184824, 30228970, 30240302, 30247094, 30257066; g) Product Code 8250-18-30, UDI/DI 00350770445472, Batch Numbers: 30181900, 30226819, 30228969, 30240301, 30247092, 30252989, 30253953, 30259565, 30265004, 30265372, 30270861; h) Product Code 8250-22, UDI/DI 00350770445489, Batch Numbers: 30184759, 30185380, 30186750, 30221235, 30226670, 30226818, 30228968, 30238123, 30238475, 30238983, 30242226, 30242037, 30252072, 30252985, 30252998, 30255676, 30254747, 30256485, 30259224, 30262039, 30264283, 30267123, 30268258, 30270504, 30270860; i) Product Code 8260-16, UDI/DI 00350770445496, Batch Numbers: 30181845, 30223861, 30256484, 30290828; j) Product Code 8260-18, UDI/DI 00350770445502, Batch Numbers: 30185408, 30233438, 30242225, 30259226, 30264282, 30290830; k) Product Code 8260-22 UDI/DI 00350770445519, Batch Numbers: 30256483, 30259564, 30290829

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93907).

Sources and updates

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